Acute Stroke Advancing Program Using Telemedicine (ASAP-Tel)

June 23, 2015 updated by: Xijing Hospital

Intravenous Thrombolysis Guided by Telemedicine Consultation System for Acute Ischemic Stroke Patients in China

The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The rate of intravenous thrombolysis with tissue-type plasminogen activator or urokinase for stroke patients was extremely low in China. It has been demonstrated that telestroke may help to increase the rate of intravenous thrombolysis and improve the stroke care quality in the local hospitals. The aim of this study is to evaluate the effectiveness and safety of decision making of intravenous thrombolysis via telemedicine consultation system for acute ischemic stroke patients in China This trial network consists of one hub hospital (Xijing Hospital) and 14 spoke hospitals in the remote area of Shanxi Province. The telemedicine consultation system is an interactive, 2-way, wireless, audiovisual system based on portable hardwares--tablet computer or smartphone. Before this study, we have been investigating the usual stroke care quality in the spoke hospitals without the guidance from the hub hospital, which will be used as the historical control of this study. After that, the teleconsultation system will be introduced.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Yulin, Shanxi, China, 719000
        • Recruiting
        • Xingyuan Hospital
      • Yulin, Shanxi, China, 719000
        • Not yet recruiting
        • Yulin First People's Hospital
      • Yulin, Shanxi, China, 719000
        • Recruiting
        • Yulin Second People's Hospital
      • Yulin, Shanxi, China, 719000
        • Not yet recruiting
        • Yuyang District People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ischemic stroke patients arriving in the local hospitals within 4.5 hours of symptom onset

Description

Inclusion Criteria:

  • Patients older than 18 years and less than 80 years
  • Acute ischemic stroke
  • Presenting to Emergency Department of spoke hospitals within 4.5 hours of stroke symptom onset
  • National Institutes of Health Stroke Scale (NIHSS) between 4 and 25
  • Signed consent form by the patient or his relatives

Exclusion Criteria:

  • Time of symptom onset unclear
  • Unlikely to complete study through 3-month follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Teleconsultation
Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares
Other: Telemedicine consultation system
Telemedicine consultation system based on portable hardwares
Historical control
Usual stroke care without the guidance from hub hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients treated with intravenous thrombolysis
Time Frame: at 4.5 hours
at 4.5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Favorite outcome at 3 months (modified Rankin score ≤2)
Time Frame: at 1 month/3 months
at 1 month/3 months
Stroke complications
Time Frame: at 24 hours/7days
They include symptomatic intracranial hemorrhage (sICH), symptomatic cerebral edema from an original brain infarction, cerebral hernia, seizure, severe extracranial bleeding, pulmonary embolism, pulmonary edema, deep venous thrombosis, and sepsis.
at 24 hours/7days
Fatal and nonfatal cardiovascular events
Time Frame: at 7 days
They include recurrent ischemic stroke, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attack, myocardial infarction, angina and heart failure
at 7 days
All cause mortality
Time Frame: at 3 months
at 3 months
Time intervals
Time Frame: at 24 hours
Those from stroke onset to arriving in emergency department(ED), and from arriving in ED to physician/CT initiation/CT interpretation/specific treatment.
at 24 hours
Length of hospitalization
Time Frame: at 3 months
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Air Force Military Medical University, China
Department of Science and Technology of Shanxi Province

Investigators

  • Study Director: Gang Zhao, MD, Xijing Hospital
  • Principal Investigator: Zhirong Liu, MD, Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xijing-Tele-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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